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Depocyte in the Treatment of CNS Relapse in Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388531
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : September 19, 2011
Information provided by:
PETHEMA Foundation

Brief Summary:
The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.

Condition or disease Intervention/treatment Phase
Lymphoblastic Leukemia Lymphoma Drug: Depocyte® Phase 2

Detailed Description:
It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter, Prospective, Open Label Trial, Uncontrolled to Determine the Efficacy and Safety of Depocyt ® for the Treatment of CNS Relapse in Adult Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
Study Start Date : March 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Intervention Details:
  • Drug: Depocyte®
    Depocyte® is a cytostatic drug

Primary Outcome Measures :
  1. The primary purpose: [ Time Frame: 1 year ]
  2. response rate after one application of DepoCyte®. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Death in induction and in CR, Time to neurological progression, The frequency of improvement in pre-existing meningeal-disease related neurological symptoms,Karnofsky Performance Status,Survival,Toxicity according to CTCAE v.3 [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse.

CNS involvement must be demonstrated by:

  • A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
  • Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks.
  • Karnofsky >60%
  • Age >18 years old
  • Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity.
  • No severe heart, lung, liver or kidney dysfunction.
  • The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures

Exclusion Criteria:

  • Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy
  • History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
  • Prior CNS relapse < 1 month before
  • uncontrolled infection
  • The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388531

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Hospital "Santa Creu i Sant Pau"
Barcelona, Spain
Hospital Clínico y Provincial de Barcelona
Barcelona, Spain
Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain
Hospital Doce de Octubre
Madrid, Spain
. Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital La Fe
Valencia, Spain
Sponsors and Collaborators
PETHEMA Foundation
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Study Chair: Josep Mª Ribera, Doctor Germans Trias i Pujol Hospital
Additional Information:
Elonen E, Almqvist A, Hänninen A et al. Intensive treatment of acute lymphatic leukaemia in adults: ALL86 protocol. Haematologica. 1991;76 (Suppl 4):133
Gökbuget N, Aguion-Freire E, Diedrich H et al. Characteristics and outcome of CNS relapse in patients with acute lymphoblastic leukemia (ALL) [abstract]. Blood. 1999;94:1287a.
Gökbuget N, Arnold R, Eggeling B et al. Prospective evaluation of neurotoxicity of prophylactic intrathecal therapy in adult acute lymphoblastic leukemia. The Hematology Journal. 2000;1:591a.
Howell SB. Liposomal cytarabine for the treatment of lymphomatous meningitis. Biological Therapy of Lymphoma. 2003;6:10-14.
Bomgaars J, Geyer J, Franklin J, et al. A phase I study of intrathecal liposomal cytarabine (DepoCyt) in pediatric patients with advanced meningeal malignancies. Proc Am Soc Clin Oncol. 2002;Abstract 433.

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Responsible Party: Pethema, pethema Identifier: NCT00388531    
Other Study ID Numbers: 2004-004414-17
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: September 2011
Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leucemia
Aggressive Non-Hodgkin-Lymphoma
CNS relapse
Cytarabine liposome
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Behavioral Symptoms